3 Series Phototherapy Unit
K-Number: K153749 · 2016-06-30
ApplicantDaavlin Distributing Company
Decision Date2016-06-30
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
3 Series Phototherapy Unit is a medical device manufactured by Daavlin Distributing Company. It received FDA 510(k) clearance on 2016-06-30 under approval number K153749. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the 3 Series Phototherapy Unit?
3 Series Phototherapy Unit is a medical device that received FDA 510(k) clearance on 2016-06-30. It is manufactured by Daavlin Distributing Company. The 510(k) number is K153749.
When was 3 Series Phototherapy Unit approved by the FDA?
3 Series Phototherapy Unit received FDA 510(k) clearance on 2016-06-30, under approval number K153749.
What company makes 3 Series Phototherapy Unit?
3 Series Phototherapy Unit is manufactured by Daavlin Distributing Company.
What is the FDA product code for 3 Series Phototherapy Unit?
The FDA product code for 3 Series Phototherapy Unit is FTC.
Other Devices by Daavlin Distributing Company
Related Devices (Code: FTC)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.